This invention relates to surgical procedures and instruments.
Many surgical procedures involve fixing soft tissue to bone, particularly in the area of shoulder surgery, for example rotator cuff repairs and instability repair. Generally, in these procedures, the surgeon forms an incision to access the surgical site and then uses one of the following techniques to reattach the soft tissue.
In one technique, the surgeon drills bone tunnels through which a suture is passed. The suture is tied through the soft tissue, which is then reapproximated back to the bone.
In an alternative technique, the surgeon drills a cavity in the bone and inserts a bone anchor. Typically, the bone anchor is formed of metal, plastic or a resorbable material, and is held in place by wings or barbs that deploy outward, by threads or by radial expansion. The anchor includes an eyelet through which a suture is threaded. After placing the anchor, the surgeon ties the suture through the soft tissue, connecting it to the eyelet of the bone anchor and thus reapproximating the soft tissue to the bone.
If multiple sutures are needed to attach the soft tissue, either technique is repeated multiple times at different locations in the bone, with a separate knot tied at each location. It is generally not possible to connect a series of anchors formed using the techniques described above, due to the difficulty of tightening stitches between the anchors.
According to one aspect of the invention, fixation of soft tissue to bone or to other soft tissue is performed using a flowable material, e.g., a polymer, in place of, or in addition to, a conventional bone anchor. Because the flowable material generally infiltrates the porous cancelous bone (also known as the xe2x80x9ctrabecular networkxe2x80x9d), the flowable material effectively forms an anchor that extends under the stronger cortical bone. As a result, an anchor formed in this manner typically exhibits a high pull-out strength. In preferred implementations, bone fragments are incorporated into the flowable material as an autologous filler, to enhance regrowth of bone into the material during natural healing.
Using preferred surgical procedures and instruments of the invention, fixation can be performed endoscopically, rather than in an open surgical procedure, resulting in less invasive treatment with minimal trauma to the patient. In preferred implementations piercing of soft tissue, drilling of a cavity, delivery of a suture and/or bone anchor (if used), and injection of the flowable material into the cavity are performed using a single endoscopic surgical instrument. In some preferred implementations knot-tying, which tends to require considerable skill and dexterity and is generally time-consuming, is not necessary. Thus, the surgical procedures of the invention are generally relatively quick, reducing trauma, and relatively easy to perform. In some implementations, the methods of the invention allow a series of connected, tensioned stitches to be made to fix a region of soft tissue to bone.
In implementations in which a conventional bone anchor is not used with the flowable material, certain risks that may be associated with such bone anchors are eliminated. For example, if a suture is used the suture does not run through an eyelet, and thus will not be microscopically damaged by friction between the suture and eyelet. Also, anchors formed using a flowable material do not rely heavily on the quality and density of the bone in which the anchor is placed, and thus a placement in compromised, low density bone may still exhibit good holding power.
The invention also features surgical procedures involving endoscopic application of polymers for other purposes, e.g., to repair a bone defect, to fill holes that are left when bone plugs are harvested, to repair osteochondritis dessicans injuries, for repair or revision of ACL grafts that exhibit micromovement, for spine fusion, for meniscal repair, and to repair bone fractures. The use of endoscopic devices and techniques significantly reduces invasiveness, generally resulting in less trauma and quicker recovery.
In one aspect, the invention features a method of securing a fixation device within an opening in a tissue, including (a) delivering a material in a flowable state to the opening, and (b) changing the state of the material so that the material forms an interference fit that secures the fixation device in the opening. The fixation device may also be secured in the opening by other, supplemental means, e.g., threaded engagement, but at least a portion of the securing is provided by the interference fit.
Implementations of this aspect of the invention may include one or more of the following features. The tissue includes bone and/or soft tissue. The fixation device is selected from the group consisting of suture, anchors, and screws. The changing step includes allowing the material to at least partially harden. The changing step includes at least partially cross-linking the material. The material includes a polymer, e.g., a thermoplastic polymer. The material includes a hydrogel. The method further includes using the fixation device to secure a second tissue to the tissue having the opening. The tissue having the opening includes bone and the second tissue includes soft tissue. The method further includes, prior to delivery of the material, piercing the soft tissue; forming the opening in an underlying area of the bone; and delivering the fixation device through the pierced tissue; wherein the fixation device is constructed to hold the soft tissue in place against the bone. The fixation device includes a suture. The suture includes a region of increased surface area to enhance anchoring, e.g., a knot, barb, braided area, ball or shaped element. All of the steps of the method are performed endoscopically, for example the steps are performed using a single endoscopic surgical tool having a plurality of attachments, and the tool is not removed from the patient until after the steps are completed. The method further includes incorporating bone fragments, e.g., fragments generated during the forming step, into the material during or prior to the delivering step. The method further includes causing the material to infiltrate the trabecular network. The material includes an osteoconductive filler. The opening is formed using micro-tooling. The opening has a diameter of less than about 3 mm. The forming step includes forming the opening using a consumable cutting tool, and the delivering step includes causing the cutting tool to melt in response to frictional heat generated during the forming step. The forming step includes forming the opening with a cutting tool having a detachable portion, and the method further includes detaching the detachable portion in the opening after the forming step is completed, to serve as the fixation device.
In another aspect, the invention features a method of anchoring soft tissue to bone including (a) piercing the soft tissue; (b) forming an opening in an underlying area of the bone; (c) delivering a material, in a flowable state, to the opening; and (d) molding a portion of the material that is not in the opening to form a fixation device constructed to hold the soft tissue in place against the bone after the material changes state to a relatively less flowable state.
Implementations of this aspect of the invention may include one or more of the following features. The molding step includes forming a portion of the material into a shape that extends radially over a portion of the soft tissue surrounding the opening. The forming step includes drilling or abrading. All of the steps are performed endoscopically. The method further includes incorporating bone fragments generated during the forming step into the material during or prior to the delivering step. The material includes an osteoconductive filler. The method further includes causing the material to infiltrate the trabecular network The opening has a diameter of less than about 3 mm, more preferably from about 0.1 to 6.0 mm. The forming step is performed using micro-tooling. The material includes a polymer. The formed portion extending radially over the soft tissue is coextensive with the material in the opening, defining a bolt-like anchor.
In a further aspect, the invention features a method of fixing soft tissue to bone including (a) at a first location, piercing through the soft tissue; (b) forming an opening in the bone underlying the soft tissue; (c) delivering a fixation device through the pierced tissue to the opening; (d) delivering a material, in a flowable state, to the opening; and (e) causing the material to change state, to a relatively less flowable state, to anchor at least a portion of the fixation device in the opening. The fixation device is selected from the group consisting of suture, anchors and screws. The method further includes (f) drawing the suture across the soft tissue to a second location, and (g) repeating steps (a)-(e) at the second location to form a stitch with the suture between the first and second locations, the stitch securing the soft tissue to the bone. The method further includes gripping the soft tissue to hold it in place against the bone. The method further includes (h) cutting the suture. Steps (a) and (h) are performed with a single tool. Steps (a)-(d) are performed endoscopically. The method further includes repeating steps (f)-(g) at subsequent locations to form a line of connected stitches. Steps (c) and (d) are performed substantially simultaneously, or, alternatively, step (c) is performed prior to step (d). The method further includes delivering the suture as a continuous length from a supply of suture material. The material is provided in the form of a pellet, powder, chips, flakes or rod, and the method further includes melting the material prior to delivery. The method further includes incorporating bone fragments generated during the forming step into the material during or prior to the delivering step. The method further includes incorporating an osteoconductive filler into the material. The method further includes causing the material, in its flowable state, to infiltrate the trabecular network The forming step includes forming a opening having a diameter of less than about 3 mm. The opening has a diameter of from about 0.1 to 6.0 mm. The forming step includes drilling or abrading. The forming step is performed using micro-tooling. The forming step is performed in the bone of a human shoulder.
In yet another aspect, the invention features a surgical instrument for tissue fixation including (a) a handpiece constructed to be held by a surgeon during a fixation procedure; and (b) a fixation instrument, mounted on the handpiece and including (i) a piercing element constructed to pierce through the tissue and form an opening therein; and (ii) a lumen for delivery of a material, in a flowable state, and a fixation device to the opening.
Implementations of this aspect of the invention may include one or more of the following features. The fixation device includes a suture. The surgical instrument further includes a suture feed mechanism constructed to deliver the suture through the lumen to the opening. The surgical instrument is constructed for endoscopic use. The surgical instrument further includes a heating element for heating the material to a molten state. The heating element is mounted on the fixation instrument. The suture feed mechanism includes a movable needle. The surgical instrument further includes a probe constructed to tighten a stitch formed with the suture, e.g., mounted on an external surface of the fixation instrument. The probe is constructed to be manually actuated by a surgeon during an endoscopic procedure. The handpiece includes a reservoir for receiving the material in solid form. The reservoir is constructed to receive a supply of pellets of the material and the handpiece further comprises a mechanism for delivering the pellets from the reservoir to the lumen. Alternatively, the reservoir is constructed to receive a supply of powdered material and the handpiece further comprises a mechanism for delivering a predetermined dose of powdered material from the reservoir to the lumen. The fixation instrument is detachable from the handpiece. The surgical instrument further includes a mixing device constructed to mix bone fragments and debris generated during opening forming into the material prior to delivery to the opening. The surgical element further includes a drive mechanism constructed to drive the piercing element and, if it is included, the suture feed mechanism. The drive mechanism is disposed in the handpiece. The surgical instrument further includes a clutch mechanism constructed to allow a surgeon to selectively engage and disengage the drive of the piercing element and the drive of the suture feed mechanism. The handpiece is constructed to receive attachments other than the fixation instrument. The piercing element is constructed to cut the suture. The fixation instrument is constructed to perform a complete fixation procedure without removing the fixation instrument from the surgical site.
In another aspect, the invention features a surgical method including (a) forming an opening in bone of a patient; (b) incorporating bone fragments generated during the forming step into a polymer as an autologous filler to form a bone/polymer blend; and (c) delivering the bone/polymer blend, in a flowable state, to the patient; wherein steps (a)-(c) are performed endoscopically. In some implementations, the bone/polymer blend is delivered to the opening.
In yet another aspect, the invention features a method of securing a first layer of soft tissue to a second layer of soft tissue including (a) forming an opening extending through both layers of soft tissue; (b) delivering a material, in a flowable state, through the opening so that the flowable material extends beyond the soft tissue at each end of the opening; and (c) causing the material to change state, to a relatively less flowable state, forming an anchor to secure the two layers of soft tissue together.
In a further aspect, the invention features a method of securing a first layer of soft tissue to a second layer of soft tissue including (a) forming an opening extending through both layers of soft tissue; (b) delivering a thermoplastic member to the opening, so that a portion of the member extends beyond the soft tissue at each end of the opening; (c) softening the extending portions of the member; and (d) forming each of the softened extending portions so that each extends radially over a portion of the soft tissue to secure the two layers of soft tissue together.
In some implementations, the member includes a hollow tube and the forming step results in a rivet-like anchor.
In another aspect, the invention features a method of securing two tissues together including (a) forming an opening extending through the two tissues, (b) delivering a material, in a flowable state, to the opening, and (c) causing the material to change state, to a relatively less flowable state; wherein the material forms an anchor that secures the two tissues together. In some implementations, the anchor is a bolt-like anchor.
In a further aspect, the invention features an endoscopic instrument for securing two tissues together including (a) a piercing device constructed to form an opening extending through the two tissues; and (b) a delivery device constructed to deliver a material, in a flowable state, and a fixation device, to the opening.
In another aspect, the invention features surgical instruments constructed to perform the steps of the methods described above. Preferred instruments are constructed to perform all steps of the methods endoscopically.